Smokeless tobacco pastille

ABSTRACT

A smokeless tobacco pastille configured for insertion into the mouth of a user is provided. The smokeless tobacco pastille can include (i) a tobacco material present in an amount of less than about 40 dry weight percent, based on the total dry weight of the pastille; (ii) at least one natural gum binder present in an amount of at least about 25 dry weight percent; and (iii) a plurality of sugar alcohols present in a total amount of at least about 40 dry weight percent, the predominant component of the plurality of sugar alcohols being isomalt or erythritol, wherein the shape of the smokeless tobacco pastille is moldable in the oral cavity.

FIELD OF THE DISCLOSURE

The present disclosure relates to products made or derived from tobacco,or that otherwise incorporate tobacco, and are intended for humanconsumption. In particular, the invention relates to smokeless tobaccoproducts containing ingredients or components obtained or derived fromplants of the Nicotiana species.

BACKGROUND OF THE DISCLOSURE

Cigarettes, cigars and pipes are popular smoking articles that employtobacco in various forms. For example, a traditional type of cigarettehas a substantially cylindrical rod-shaped structure and includes acharge, roll or column of smokable material, such as shredded tobacco(e.g., in cut filler form), surrounded by a paper wrapper, therebyforming a so-called “smokable rod”, “tobacco rod” or “cigarette rod.”Tobacco also may be enjoyed in a so-called smokeless form. Particularlypopular smokeless tobacco products are employed by inserting some formof processed tobacco or tobacco-containing formulation into the mouth ofthe user. See for example, the types of representative smokeless tobaccoproducts, as well as the various smokeless tobacco formulations,ingredients and processing methodologies, referenced in the backgroundart set forth in U.S. Pat. Pub. Nos. 2011/0303511 to Brinkley et al. and2013/0206150 to Duggins et al.; which are incorporated herein byreference.

It would be desirable to provide an enjoyable form of a tobacco product,such as a smokeless tobacco product, and to provide processes forpreparing tobacco-containing compositions suitable for use in smokelesstobacco products.

SUMMARY OF THE DISCLOSURE

The present disclosure relates to a dissolvable smokeless tobaccopastille product configured for insertion into the mouth of a user andprocesses for preparing a smokeless tobacco composition suitable for usein a smokeless tobacco product. The smokeless tobacco composition of thedisclosure provides a dissolvable smokeless tobacco product having alightly chewable quality and is typically soft and flexible enough to bemoldable in the mouth by the user. In certain embodiments, the pastilleof the invention utilizes tobacco material in the form of an extract(e.g., an aqueous extract) or in the form of finely-milled tobaccoparticles, such as particles with an average particle size of less thanabout 50 microns.

In one aspect, the invention provides a smokeless tobacco pastilleconfigured for insertion into the mouth of a user, the smokeless tobaccopastille comprising: (i) a tobacco material present in an amount of lessthan about 40 dry weight percent, based on the total dry weight of thepastille; (ii) at least one natural gum binder present in an amount ofat least about 25 dry weight percent; and (iii) a plurality of sugaralcohols present in a total amount of at least about 40 dry weightpercent, the predominant component of the plurality of sugar alcoholsbeing isomalt or erythritol, wherein the shape of the smokeless tobaccopastille is moldable in the oral cavity.

The tobacco material in the product can vary. In certain embodiments,the only tobacco material present in the pastille is in the form of oneor more tobacco extracts (e.g., aqueous extracts), and those extractsare typically present in amount of less than about 10 dry weightpercent. The tobacco extract can be in the form of pharmaceutical gradenicotine. In other embodiments, the tobacco material comprises aparticulate tobacco material (such as finely milled tobacco particles)present in an amount of less than about 12 dry weight percent. Inaddition to tobacco, the pastille can further include a non-tobaccobotanical component, and typically the total amount of tobacco materialand non-tobacco botanical component remains less than about 40 dryweight percent. Exemplary non-tobacco botanical components includerosemary, oregano, sage, hibiscus, clove, rose hip, yerba mate, cocoa,turmeric, guayusa, honeybush, green tea, black tea, rooibos, andcombinations thereof.

In certain embodiments, the smokeless tobacco pastille includes one ormore of green tea, guayusa, rooibos, or honeybush in an amountsufficient to impart certain desirable sensory characteristics to theproduct. Exemplary amounts include green tea, guayusa, rooibos, orhoneybush present as an aqueous extract in an amount of about 1 to about5 dry weight percent, or in the form of a powder in an amount of about 5to about 10 dry weight percent.

The natural gum binder is typically gum arabic; however, other naturalgums could also be used such as xanthan gum, guar gum, ghatti gum, gumtragacanth, karaya gum, locust bean gum, gellan gum, and combinationsthereof. The natural gum binder is typically present in an amount ofabout 25 to about 40 dry weight percent.

The plurality of sugar alcohols, in addition to isomalt (or erythritol),can include one or more different sugar alcohols selected from the groupconsisting of erythritol, arabitol, ribitol, polyglycitol, maltitol,dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, andcombinations thereof. Typically, the isomalt or erythritol comprises atleast about 75% of the total dry weight of the plurality of sugaralcohols. In certain embodiments, the plurality of sugar alcoholscomprises at least two additional sugar alcohols in addition to thepredominant component, such as two additional sugar alcohols present ina dry weight ratio of at least about 3:1. In one embodiment, erythritolor sorbitol and either maltitol or xylitol are present in a dry weightratio of at least about 3:1, with erythritol or sorbitol being thelarger component. Where erythritol is the predominant component of thesugar alcohols instead of isomalt, isomalt can be substituted forerythritol as the larger component of the two additional sugar alcohols.

In addition to the ingredients noted above, other components can beadded to the pastille formulation such as flavorants, sweeteners (e.g.,sucralose), additional binders, emulsifiers, disintegration aids,humectants (e.g., glycerin), colorants, buffering agents, and mixturesthereof. Further, the pastille of the invention can include an outercoating and can be starch-moulded as described herein.

In one particular embodiment, the smokeless tobacco pastille comprises:

(i) at least one solid particulate component, in the form of tobaccoparticles or non-tobacco botanical particles or both, the particulatecomponent present in an amount of at least about 5 dry weight percent;

(ii) a natural gum binder present in an amount of at least about 25 dryweight percent;

(iii) a plurality of sugar alcohols present in an amount of at leastabout 40 dry weight percent, the plurality of sugar alcohols includingisomalt or erythritol in an amount of at least about 75% of the totaldry weight of sugar alcohols;

(iv) salt present in an amount of at least about 4 dry weight percent;and

(v) a humectant in an amount of at least about 1 dry weight percent. Thepastille may further include a tobacco extract or non-tobacco botanicalextract present in an amount of at least about 0.1 dry weight percent.

In another embodiment, the smokeless tobacco pastille comprises:

(i) at least one aqueous tobacco extract or other aqueous non-tobaccobotanical extract or both, the extract component present in an amount ofat least about 1 dry weight percent;

(ii) a natural gum binder present in an amount of at least about 30 dryweight percent;

(iii) a plurality of sugar alcohols present in an amount of at leastabout 45 dry weight percent, the plurality of sugar alcohols includingisomalt or erythritol in an amount of at least about 75% of the totaldry weight of sugar alcohols;

(iv) salt present in an amount of less than about 4 dry weight percent;and

(v) a humectant in an amount of at least about 1 dry weight percent. Inthis embodiment, it is typical not to include any solid, non-dissolvablecomponents (such as particulate tobacco) in the formulation and insteaduse only aqueous-soluble components.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure now will be described more fully hereinafter. Thedisclosure may be embodied in many different forms and should not beconstrued as limited to the aspects set forth herein; rather, theseaspects are provided so that this disclosure will satisfy applicablelegal requirements. As used in this specification and the claims, thesingular forms “a,” “an,” and “the” include plural referents unless thecontext clearly dictates otherwise. Reference to “dry weight percent” or“dry weight basis” refers to weight on the basis of dry ingredients(i.e., all ingredients except water).

The disclosure provides a smokeless tobacco composition suitable fororal use. The smokeless tobacco composition generally includes a tobaccomaterial formulation and one or more additional components that combineto form a dissolvable and lightly chewable smokeless tobacco pastilleproduct for oral use. As used herein, the term “pastille” refers to adissolvable oral product made by solidifying a liquid or gelcomposition, such as a composition that includes a gelling or bindingagent, so that the final product is a hardened solid gel. As usedherein, the terms “dissolve,” “dissolving,” and “dissolvable” refer tocompositions having aqueous-soluble components that interact withmoisture in the oral cavity and enter into solution, thereby causinggradual consumption of the product.

In certain embodiments, the products of the disclosure are characterizedby sufficient cohesiveness to withstand light chewing action in the oralcavity without rapidly disintegrating. Additionally, certain embodimentsof the pastille products of the invention can be described as moldablein the oral cavity, meaning the product is soft enough to allow theconsumer to manipulate the shape of the product during use. However, theproducts of the disclosure typically do not exhibit a highly deformablechewing quality as found in conventional chewing gum.

Time of product use can vary, and depends, for example, on the exactproduct formulation and the manner in which the product is manipulatedin the mouth (e.g., light or hard chewing action, frequent movement orinfrequent movement, etc.). In certain embodiments, the pastilleproducts of the invention are adapted to remain in the oral cavity priorto complete dissolution for at least about 15 minutes, at least about 20minutes, at least about 30 minutes, or at least about 40 minutes.

The base pastille formulation of the invention includes both a gumcomponent and a plurality of sugar alcohols as the primary components ofthe formulation. The formulations of the invention are adaptable inorder to provide organoleptic experiences similar to traditionalsmokeless tobacco products with enhanced characteristics not found intraditional products. For example, combination of the base pastilleformulation of the invention with a relatively high salt content and amilled particulate component (e.g., milled tobacco and/or a milledbotanical from another plant source) creates a product, in certainembodiments, that provides sensory characteristics reminiscent oftraditional oral snuff tobacco products (e.g., tobacco “dip”) with oneor more enhanced properties, such as reduced difficulty in retaining theproduct at one location in the mouth (i.e., elimination of unwantedproduct dispersal in the mouth), a reduction (or even elimination insome cases) in need to expectorate during use, reduction in mouth andthroat irritation, reduction in undesirable mouthfeel (e.g., undesirableslickness or slimy texture), and reduction in waste requiring disposalfollowing product use. In another example, combination of the basepastille formulation of the invention with a moderate salt content and alittle or no aqueous-insoluble components creates a product, in certainembodiments, that provides sensory characteristics reminiscent oftraditional tobacco snus with one or more enhanced properties, such aselimination of the need for a pouch (which may cause discomfort in themouth), elimination of possible product dispersal in the mouth (such asif a snus pouch breaks), reduced time until flavor delivery to theconsumer (as there is no pouch through which flavors must first pass),reduction in waste requiring disposal following product use, and aneasily discerned product use endpoint due to the dissolvable nature ofthe product.

The smokeless tobacco pastilles of the disclosure typically include atleast one tobacco material (e.g., a particulate tobacco material ortobacco-derived extract), at least one binder or gelling agent in theform of a natural gum, and a plurality of sugar alcohols.

The products of the disclosure will typically incorporate some form of aplant of the Nicotiana species, and most preferably, those compositionsor products incorporate some form of tobacco. The selection of the plantfrom the Nicotiana species can vary; and in particular, the types oftobacco or tobaccos may vary. Tobaccos that can be employed includeflue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., IndianKurnool and Oriental tobaccos, including Katerini, Prelip, Komotini,Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured(e.g., Passanda, Cubano, Jatin and Bezuki tobaccos), light air cured(e.g., North Wisconsin and Galpao tobaccos), Indian air cured, RedRussian and Rustica tobaccos, as well as various other rare or specialtytobaccos. Descriptions of various types of tobaccos, growing practicesand harvesting practices are set forth in Tobacco Production, Chemistryand Technology, Davis et al. (Eds.) (1999), which is incorporated hereinby reference. Nicotiana species can be derived usinggenetic-modification or crossbreeding techniques (e.g., tobacco plantscan be genetically engineered or crossbred to increase or decreaseproduction of or to other change certain components, characteristics orattributes). Additional information on types of Nicotiana speciessuitable for use in the present invention can be found in US Pat. Appl.Pub. No. 2012/0192880 to Dube et al., which is incorporated by referenceherein. Tobacco plants can be grown in greenhouses, growth chambers, oroutdoors in fields, or grown hydroponically.

The portion or portions of the plant of the Nicotiana species usedaccording to the present invention can vary. For example, virtually allof the plant (e.g., the whole plant) can be harvested, and employed assuch. Alternatively, various parts or pieces of the plant can beharvested or separated for further use after harvest. For example, theleaves, stem, stalk, roots, lamina, flowers, seed, and various portionsand combinations thereof, can be isolated for further use or treatment.The plant material of the invention may thus comprise an entire plant orany portion of a plant of the Nicotiana species. See, for example, theportions of tobacco plants set forth in US Pat. Appl. Pub. Nos.2011/0174323 to Coleman, III et al. and 2012/0192880 to Dube et al.,which are incorporated by reference herein.

The plant of the Nicotiana species can be employed in either an immatureor mature form, and can be used in either a green form or a cured form,as described in 2012/0192880 to Dube et al., which is incorporated byreference herein.

The tobacco material can be subjected to various treatment processessuch as, refrigeration, freezing, drying (e.g., freeze-drying orspray-drying), irradiation, yellowing, heating, cooking (e.g., roasting,frying or boiling), fermentation, bleaching, or otherwise subjected tostorage or treatment for later use. Exemplary processing techniques aredescribed, for example, in US Pat. Appl. Pub. Nos. 2009/0025739 toBrinkley et al. and 2011/0174323 to Coleman, III et al., which areincorporated by reference herein.

Tobacco materials can be treated with enzymes and/or probiotics beforeor after harvest, as discussed in U.S. patent application Ser. No.13/444,272 to Marshall et al., filed on Apr. 11, 2012 and U.S. patentapplication Ser. No. 13/553,222 to Moldoveanu, filed on Jul. 19, 2012,which are incorporated herein by reference. Tobacco materials may beirradiated, pasteurized, or otherwise subjected to controlled heattreatment. Representative processes are set forth in US Pat. Pub. Nos.2009/0025738 to Mua et al.; 2009/0025739 to Brinkley et al.; and2011/0247640 to Beeson et al., which are incorporated herein byreference. The tobacco material can be brought into contact with animprinted polymer or non-imprinted polymer such as described, forexample, in US Pat. Pub. Nos. 2007/0186940 to Bhattacharyya et al;2011/0041859 to Rees et al.; 2011/0159160 to Jonsson et al; and2012/0291793 to Byrd et al., all of which are incorporated herein byreference.

A harvested portion or portions of the plant of the Nicotiana speciescan be physically processed. A portion or portions of the plant can beseparated into individual parts or pieces (e.g., roots can be removedfrom stalks, stems can be removed from stalks, leaves can be removedfrom stalks and/or stems, petals can be removed from the remainingportion of the flower). The harvested portion or portions of the plantcan be further subdivided into parts or pieces (e.g., shredded, cut,comminuted, pulverized, milled or ground into pieces or parts that canbe characterized as filler-type pieces, granules, particulates or finepowders). The harvested portion or portions of the plant can besubjected to external forces or pressure (e.g., by being pressed orsubjected to roll treatment). When carrying out such processingconditions, the harvested portion or portions of the plant can have amoisture content that approximates its natural moisture content (e.g.,its moisture content immediately upon harvest), a moisture contentachieved by adding moisture to the harvested portion or portions of theplant, or a moisture content that results from the drying of theharvested portion or portions of the plant.

In certain embodiments, the tobacco material is used in a form that canbe described as particulate (i.e., shredded, ground, granulated, orpowder form). The manner by which the tobacco material is provided in afinely divided or powder type of form may vary. Preferably, plant partsor pieces are comminuted, ground or pulverized into a particulate formusing equipment and techniques for grinding, milling, or the like. Mostpreferably, the plant material is relatively dry in form during grindingor milling, using equipment such as hammer mills, cutter heads, aircontrol mills, or the like. For example, tobacco parts or pieces may beground or milled when the moisture content thereof is less than about 15weight percent or less than about 5 weight percent. Most preferably, thetobacco material is employed in the form of parts or pieces that have anaverage particle size less than about 50 microns. In one embodiment, theaverage particle size of the tobacco particles may be less than or equalto about 25 microns. In some instances, the tobacco particles may besized to pass through a screen mesh. If desired, air classificationequipment may be used to ensure that small sized tobacco particles ofthe desired sizes, or range of sizes, may be collected. If desired,differently sized pieces of granulated tobacco may be mixed together.Use of micro-milled tobacco particles (or other micro-sized botanicalcomponents) can be advantageous where the user prefers to reduce oreliminate product waste after use.

In certain embodiments, at least a portion of the tobacco materialemployed in the tobacco composition or product can have the form of anextract. Tobacco extracts can be obtained by extracting tobacco using asolvent having an aqueous character such as distilled water or tapwater. As such, aqueous tobacco extracts can be provided by extractingtobacco with water, such that water insoluble pulp material is separatedfrom the aqueous solvent and the water soluble and dispersible tobaccocomponents dissolved and dispersed therein. Exemplary techniques forextracting components of tobacco are described in U.S. Pat. No.4,144,895 to Fiore; U.S. Pat. No. 4,150,677 to Osborne, Jr. et al.; U.S.Pat. No. 4,267,847 to Reid; U.S. Pat. No. 4,289,147 to Wildman et al.;U.S. Pat. No. 4,351,346 to Brummer et al.; U.S. Pat. No. 4,359,059 toBrummer et al.; U.S. Pat. No. 4,506,682 to Muller; U.S. Pat. No.4,589,428 to Keritsis; U.S. Pat. No. 4,605,016 to Soga et al.; U.S. Pat.No. 4,716,911 to Poulose et al.; U.S. Pat. No. 4,727,889 to Niven, Jr.et al.; U.S. Pat. No. 4,887,618 to Bernasek et al.; U.S. Pat. No.4,941,484 to Clapp et al.; U.S. Pat. No. 4,967,771 to Fagg et al.; U.S.Pat. No. 4,986,286 to Roberts et al.; U.S. Pat. No. 5,005,593 to Fagg etal.; U.S. Pat. No. 5,018,540 to Grubbs et al.; U.S. Pat. No. 5,060,669to White et al.; U.S. Pat. No. 5,065,775 to Fagg; U.S. Pat. No.5,074,319 to White et al.; U.S. Pat. No. 5,099,862 to White et al.; U.S.Pat. No. 5,121,757 to White et al.; U.S. Pat. No. 5,131,414 to Fagg;U.S. Pat. No. 5,131,415 to Munoz et al.; U.S. Pat. No. 5,148,819 toFagg; U.S. Pat. No. 5,197,494 to Kramer; U.S. Pat. No. 5,230,354 toSmith et al.; U.S. Pat. No. 5,234,008 to Fagg; U.S. Pat. No. 5,243,999to Smith; U.S. Pat. No. 5,301,694 to Raymond et al.; U.S. Pat. No.5,318,050 to Gonzalez-Parra et al.; U.S. Pat. No. 5,343,879 to Teague;U.S. Pat. No. 5,360,022 to Newton; U.S. Pat. No. 5,435,325 to Clapp etal.; U.S. Pat. No. 5,445,169 to Brinkley et al.; U.S. Pat. No. 6,131,584to Lauterbach; U.S. Pat. No. 6,284,875 to Turpen et al.; U.S. Pat. No.6,298,859 to Kierulff et al.; U.S. Pat. No. 6,772,767 to Mua et al.;U.S. Pat. No. 6,817,970 to Berit et al.; U.S. Pat. No. 6,906,172 toBratcher et al.; U.S. Pat. No. 7,034,128 to Turpen et al.; U.S. Pat. No.7,048,211 to Bratcher et al.; and U.S. Pat. No. 7,337,782 to Thompson,all of which are incorporated by reference herein. See also, theultrafiltered translucent tobacco extracts set forth in US Pat. Appl.Pub. Nos. 2013/0074855 and 2013/0074856, both to Holton, Jr., which areincorporated by reference herein.

The tobacco-derived extract will typically comprise a mixture of desiredcomponents isolated from a plant of the Nicotiana species by variousmeans. However, if desired, the tobacco-derived extract can be highlypurified with respect to a single component of the extract or a smallnumber of extract components. Typical separation processes that canfurther purify or isolate components of a tobacco extract include one ormore process steps such as solvent extraction (e.g., using polarsolvents, organic solvents, or supercritical fluids), chromatography(e.g., preparative liquid chromatography), clarification, distillation,filtration (e.g., ultrafiltration), recrystallization, and/orsolvent-solvent partitioning. In some embodiments, a plant or a portionthereof is pre-treated, e.g., to liberate certain compounds to make thedesired compounds available for more efficient separation. In someembodiments, multiple methods are used to isolate and/or purify thedesired compounds. See, for example, the description of isolated tobaccocomponents and techniques for isolation in US Pat. Appl. Pub. Nos.2011/0174323 to Coleman, III et al.; 2011/0259353 to Coleman, III etal.; 2012/0192880 to Dube et al.; 2012/0192882 to Dube et al.; and2012/0211016 to Byrd, Jr. et al., which are incorporated by referenceherein.

Reference to “tobacco extract” as explained above encompasses extractshighly purified with respect to one or a few components thereof. Forexample, highly purified tobacco-derived nicotine (e.g., pharmaceuticalgrade nicotine having a purity of greater than 98% or greater than 99%)or a derivative thereof can be used in the present invention.Representative nicotine-containing extracts can be provided using thetechniques set forth in U.S. Pat. No. 5,159,942 to Brinkley et al.,which is incorporated herein by reference. Extracts containingrelatively high nicotine content can be buffered, e.g., using bufferingagents such as citric acid to lower the pH of the extracts.

The form of the tobacco extract (or isolate therefrom) obtainedaccording to the present invention can vary. Typically, the isolate isin a solid, liquid, or semi-solid or gel form. The formulation can beused in concrete, absolute, or neat form. Solid forms of the tobaccoisolate can include spray-dried and freeze-dried forms. Liquid forms ofthe tobacco isolate can include formulations contained within aqueous ororganic solvent carriers.

In certain embodiments, the pastille of the invention can includenicotine in any form from any source, whether tobacco-derived orsynthetically-derived. Normally, nicotinic compounds used in the presentinvention are selected from the group consisting of nicotine base,nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate,nicotine bitartrate, nicotine sulfate, nicotine zinc chloride such asnicotine zinc chloride monohydrate and nicotine salicylate. In someembodiments, nicotine is in its free base form, which can optionally besorbed on a carrier (e.g., microcrystalline cellulose) for inclusion ina smokeless tobacco product. See, for example, the nicotine/carriercompositions set forth in US Pat. Pub. No. 2004/0191322 to Hansson,which is incorporated by reference herein.

The relative amount of tobacco material within the smokeless tobaccocomposition may vary, and depends in part on the type of tobaccomaterial employed (e.g., milled tobacco or tobacco extract). Preferably,the total amount of tobacco material (from any source including tobaccoextracts or isolates and particulate tobacco material) formulationwithin the smokeless tobacco pastille is between about 0.1 and about 40weight percent on a dry weight basis, more typically between about 0.2and about 20 dry weight percent (e.g., between about 0.3 and about 12dry weight percent). For embodiments containing only tobacco extract asthe tobacco component (including pharmaceutical grade nicotine), thepastille will typically contain no more than about 10 dry weight percentof tobacco component, such as no more than about 8 dry weight percent,no more than about 5 dry weight percent, or no more than about 3 dryweight percent (e.g., about 0.1 to about 10 dry weight percent). Forembodiments containing a particulate tobacco component (e.g., a finelymilled tobacco), either as the sole tobacco component or in combinationwith a tobacco extract, the pastille will typically contain no more thanabout 12 dry weight percent of tobacco component, such as no more thanabout 10 dry weight percent, no more than about 8 dry weight percent, orno more than about 6 dry weight percent (e.g., about 1 to about 12 dryweight percent). The amount of tobacco material (or combination oftobacco material with other botanical components) will typically notexceed 40 dry weight percent in order to prevent the level of cellulosicmaterial/biomass in the product from undesirably affecting thecohesiveness of the product.

In addition to (or in lieu of in certain embodiments) the above-notedtobacco material, products of the invention can include a furthernon-tobacco botanical material. As used herein, the term “botanicalmaterial” refers to any plant material, including plant material in itsnatural form and plant material derived from natural plant materials,such as extracts or isolates from plant materials or treated plantmaterials (e.g., plant materials subjected to heat treatment,fermentation, or other treatment processes capable of altering thechemical nature of the material). For the purposes of the presentdisclosure, a “botanical material” includes but is not limited to“herbal materials,” which refer to seed-producing plants that do notdevelop persistent woody tissue and are often valued for their medicinalor sensory characteristics (e.g., teas or tisanes). Certain botanicalmaterials of this type are sometimes referred to as dietary supplements,nutraceuticals, “phytochemicals” or “functional foods.” Exemplarybotanical materials, many of which are associated with antioxidantcharacteristics, include without limitation acai berry, alfalfa,allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot,black pepper, blueberries, borage seed oil, bugleweed, cacao, calamusroot, catnip, catuaba, cayenne pepper, chaga mushroom, chervil,cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingkobiloba, Saint John's Wort, saw palmetto, green tea, black tea, blackcohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion,grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew,ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava,lavender, licorice, marjoram, milk thistle, mints (menthe), oolong tea,beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover,rooibos (red or green), rosehip, rosemary, sage, clary sage, savory,spearmint, spirulina, slippery elm bark, sorghum bran hi-tannin, sorghumgrain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutukola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen,yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera,withania somnifera, and silybum marianum. When present in thecomposition, such botanical materials can be used in the same formsnoted above with respect to tobacco (e.g., milled particulates orextracts) and the amounts utilized are typically such that the totaltobacco and non-tobacco botanical material falls within the totalamounts given above for tobacco materials in the compositions of theinvention. In other words, the total content of tobacco and non-tobaccobotanical materials will typically be between about 0.1 and about 40weight percent on a dry weight basis, more typically between about 0.2and about 20 dry weight percent (e.g., between about 0.3 and about 12dry weight percent). Most preferably, the non-tobacco botanical materialis employed in the form of an aqueous extract (e.g., freeze-dried orspray-dried extracts) or in powder form (e.g., having an averageparticle size less than about 50 microns).

In certain embodiments, the non-tobacco botanical will provideadvantageous sensory characteristics (e.g., taste, aroma, or color) orother functional benefits, such as function as a binder or filler. Incertain embodiments, the non-tobacco botanical may be associated withdesirable bioactivity or health-related effects such as antioxidantqualities. In particularly preferred embodiments, the non-tobaccobotanical components will complement the sensory characteristicsassociated with tobacco-derived materials in the formulation, and insome cases, will even contribute tobacco-like sensory characteristics.In some embodiments, the presence of the non-tobacco botanical isassociated with mouth and throat sensory characteristics that are notdissonant with the overall desirable sensory characteristics of theproduct and, in some cases, can contribute to a reduction in mouthand/or throat irritation otherwise associated with the formulation.Green tea (Camellia sinesis), guayusa, rooibos (particularly greenrooibos) and honeybush (particularly red honeybush) are particularlyadvantageous non-tobacco botanical components that can lead to thedesirable characteristics set forth above.

Honeybush (genus Cyclopia) is a flowering plant in the legume familynamed for the honey-like aroma of its flowers. The honeybush plant isunique to South Africa and exemplary species include Cyclopiagenistoides, Cyclopia longifolia, Cyclopia maculata, Cyclopiasubternata, and Cyclopia intermedia. The leaves of the honeybush plantare sometimes used in tisanes. The shoots (leaves and twigs) of theHoneybush plant are typically harvested and chopped or shredded.Thereafter, the plant material can be used as-is in “green” form, whichis lighter in color and less sweet, or subjected to a fermenting processto produce “red” honeybush, which enhances the sweetness and produces arich amber color. Honeybush in either form can be purchased fromspecialty tea distributors. The honeybush plant is rich in antioxidants,such as mangiferin, and is being studied for its possiblecancer-protective benefits. See Kokotkiewicz, A & Luczkiewics, M. 2009.Honeybush (Cyclopia sp.)—A rich source of compounds with highantimutagenic properties. Fitoterapia 80 (2009) 3-11. In certainembodiments, honeybush is present in an amount of up to about 15 dryweight percent, such as about 1 to about 5 dry weight percent in aqueousextract form, or about 5 to about 10 dry weight percent in powder form.

Like honeybush, rooibos (Aspalathus linearis) is also a flowering plantin the legume family indigenous to South Africa, and its leaves are alsoused in tisanes. The rooibos plant is harvested and processed in amanner similar to honeybush described above, and is available in greenor red (fermented) forms. Rooibos in either form can be purchased fromspecialty tea distributors. The rooibos plant is rich in antioxidantsand is being studied for its possible health-protective benefits. SeeThe Science Behind Roobios—South Africa's Unique and Healthy Herbal Tea,South African Rooibos Council, July 2013. In certain embodiments,rooibos is present in an amount of up to about 15 dry weight percent,such as about 1 to about 5 dry weight percent in aqueous extract form,or about 5 to about 10 dry weight percent in powder form.

The moisture content of the tobacco material formulation (or otherbotanical) prior to mixing with any liquid substances to form thesmokeless tobacco composition may vary. Most preferably, the moisturecontent of the tobacco material formulation is less than about 10 weightpercent, and may be less than about 5 percent, and is often less thanabout 2.5 weight percent. The manner by which the moisture content ofthe tobacco material formulation is controlled may vary. For example thetobacco material formulation may be subjected to thermal or convectionheating. As a specific example, the tobacco material formulation may beoven-dried, in warmed air at temperatures of about 40° C. to about 95°C. for a length of time appropriate to attain the desired moisturecontent. For example, the tobacco material formulation may be dried forabout 12 hours to about 24 hours at about 54° C. to about 60° C.

A binder (or combination of binders) may be employed in amountssufficient to provide the desired physical attributes and physicalintegrity to the smokeless tobacco composition. In certain embodiments,the binder material includes a natural gum. As used herein, a naturalgum refers to polysaccharide materials of natural origin that are usefulas thickening or gelling agents. Representative natural gums derivedfrom plants, which are typically water soluble to some degree, includexanthan gum, guar gum, gum arabic, ghatti gum, gum tragacanth, karayagum, locust bean gum, gellan gum, and combinations thereof. Arepresentative amount of binder (e.g., natural gum) is between about 25and about 40 percent of the total dry weight of the composition. Incertain embodiments, the binder component(s) of the composition will bepresent in an amount of at least about 20 dry weight percent, or atleast about 25 dry weight percent, or at least about 28 dry weightpercent. Preferably, the total amount of binder within the compositionwill not exceed about 38 percent of the total dry weight of thecomposition, or will not exceed about 36 dry weight percent, or will notexceed about 34 dry weight percent.

The smokeless tobacco compositions of the disclosure typically includesa plurality of sugar alcohols, which are particularly advantageous asfiller components in the pastilles of the disclosure because suchmaterials contribute some sweetness and do not disrupt the desiredchewable characteristics of the final product. Sugar alcohols arepolyols derived from monosaccharides or disaccharides that have apartially or fully hydrogenated form. Exemplary sugar alcohols havebetween about 4 and about 20 carbon atoms and include erythritol,arabitol, ribitol, isomalt, polyglycitol, maltitol, dulcitol, iditol,mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,hydrogenated starch hydrolysates). A sugar alcohol is typically added tocompositions of the disclosure in the form of an aqueous solution orsuspension, such as a solution or suspension with a solids content ofabout 50 to about 90 weight percent. Sugar alcohols can fulfill multiplefunctions, such as providing sweetness, enhancing certain organolepticproperties such as texture and mouthfeel, enhancing cohesiveness orcompressibility of the product, and the like.

A combination of sugar alcohols is typically utilized in the presentinvention. The exact combination of sugar alcohols used in any givenformulation can be selected based on a number of factors, includinglaxation threshold, relative sweetness, calorie content, glycemic index,degree of hygroscopicity, and the like. In the present invention, thepredominant sugar alcohol component is typically isomalt, and isomalt istypically used in an amount of at least about 75% of the total dryweight of sugar alcohols, such as at least about 80% by dry weight.Exemplary weight percentages of isomalt as a percentage of total sugaralcohol dry weight is about 75 to about 85% (e.g., about 80 to about85%). In certain embodiments, isomalt is replaced with erythritol as thepredominant sugar alcohol at the percentages noted above. Certainembodiments utilizing erythritol as the predominant sugar alcohol willexhibit a slight cooling sensation as compared to embodiments comprisingpredominantly isomalt.

The combination of sugar alcohols will also include at least oneadditional sugar alcohol, and in preferred embodiments, will include atleast two additional sugar alcohols. In certain embodiments, theadditional sugar alcohols will comprise two additional sugar alcohols ina dry weight ratio of at least about 3:1, at least about 3.5:1, or atleast about 4:1. Exemplary sugar alcohols useful as the larger componentin the ratio include erythritol or sorbitol. In embodiments whereerythritol is instead used as the predominant sugar alcohol, isomaltcould also be used as the larger component. Examples of the minorcomponent in the ratio include maltitol, sorbitol, or xylitol.

The total sugar alcohol content of the pastilles of the invention willtypically range from about 40 to about 60 dry weight percent, such asabout 42 to about 58 dry weight percent, or about 46 to about 53 dryweight percent. The sugar alcohol content of the pastille will typicallybe at least about 42 dry weight percent, or at least about 44 dry weightpercent, or at least about 46 dry weight percent. The sugar alcoholcontent of the pastille will typically not exceed about 58 dry weightpercent, such as no more than about 56 dry weight percent, or no morethan about 54 dry weight percent.

A salt (e.g., sodium chloride, flour salt) may be employed in amountssufficient to provide desired sensory attributes to the smokelesstobacco composition. When present, a representative amount of salt is atleast about 0.5 dry weight percent, or at least about 1.0 dry weightpercent, or at least about 1.5 dry weight percent, but will typicallymay make up less than about 8 percent of the total dry weight of thecomposition (e.g., about 0.5 to about 7 dry weight percent).

A humectant (e.g., glycerin) may be employed in amounts sufficient toprovide desired moisture attributes to the smokeless tobaccocomposition. Further, in some instances, the humectant may impartdesirable flow characteristics to the smokeless tobacco composition fordepositing in a starch mould. When present, a representative amount ofhumectant is at least about 0.5 dry weight percent, or at least about1.0 dry weight percent, or at least about 1.5 dry weight percent, butwill typically make up less than about 5 percent of the total dry weightof the composition (e.g., about 0.5 to about 4 dry weight percent).

The pastilles of the invention may further include one or moreflavorants. As used herein, a “flavorant” or “flavoring agent” is anyflavorful or aromatic substance capable of altering the sensorycharacteristics associated with the smokeless tobacco composition.Exemplary sensory characteristics that can be modified by the flavorantinclude, taste, mouthfeel, moistness, coolness/heat, and/orfragrance/aroma. The flavorants can be natural or synthetic, and thecharacter of these flavors can be described as, without limitation,fresh, sweet, herbal, confectionery, floral, fruity or spice. Specifictypes of flavors include, but are not limited to, vanilla, coffee,chocolate, cream, mint (e.g., mint oil), spearmint, menthol, peppermint,wintergreen, lavender, cardamon, nutmeg, cinnamon, clove, cascarilla,sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon,orange, apple, peach, lime, cherry, and strawberry. Flavorants utilizedin the disclosure also can include components that are consideredmoistening, cooling or smoothening agents, such as eucalyptus. Theseflavors may be provided neat (i.e., alone) or in a composite (e.g.,spearmint and menthol or orange and cinnamon). In some instances, theflavorant may be provided in a spray-dried form or a liquid form.Flavorants are typically present in an amount of about 0.3 to about 10dry weight percent, often about 0.4 to about 5 dry weight percent, andmost often about 1 to about 3 dry weight percent.

Sweeteners can be used in natural or artificial form or as a combinationof artificial and natural sweeteners to provide additional sweetness (inaddition to the plurality of sugar alcohols). In one embodiment,sucralose is the primary sweetener ingredient. When present, arepresentative amount of additional sweetener is about 0.01 to about 0.5dry weight percent, often about 0.03 to about 0.1 dry weight percent,and most often about 0.04 to about 0.08 dry weight percent.

Further ingredients can be admixed with, or otherwise incorporatedwithin, the smokeless tobacco compositions according to the invention.The ingredients can be artificial, or can be obtained or derived fromherbal or biological sources. Exemplary types of additional ingredientsinclude additional organic and/or inorganic fillers (e.g., grains,puffed grains, dextrose, calcium carbonate, calcium phosphate, cornstarch, finely divided cellulose, and the like); additional binders(e.g., povidone, sodium carboxymethylcellulose and other modifiedcellulosic types of binders, sodium alginate, starch-based binders,lecithin, and the like); pH adjusters or buffering agents (e.g., metalhydroxides, preferably alkali metal hydroxides such as sodium hydroxideand potassium hydroxide, and other alkali metal buffers such as metalcarbonates, preferably potassium carbonate or sodium carbonate, or metalbicarbonates such as sodium bicarbonate, and the like); colorants (e.g.,dyes and pigments, including caramel coloring and titanium dioxide, andthe like); effervescing materials such as certain acid/basecombinations; oral care additives (e.g., thyme oil, eucalyptus oil, andzinc); preservatives (e.g., potassium sorbate, and the like); aminoacids; and disintegration aids (e.g., microcrystalline cellulose,croscarmellose sodium, crospovidone, sodium starch glycolate,pregelatinized corn starch, and the like). Exemplary encapsulatedadditives are described, for example, in WO 2010/132444 to Atchley,which has been previously incorporated by reference herein. See also,the smokeless tobacco ingredients set forth in US Pat. Pub. Nos.2012/0055494 to Hunt et al. and 2012/0199145 to Byrd et al., which areincorporated by reference herein.

As noted above, the basic pastille formulation of the invention providesa platform for developing smokeless tobacco products that arereminiscent of various traditional smokeless tobacco categories. Forexample, an exemplary pastille product useful for providing a sensoryexperience similar to traditional oral snuff tobacco comprises: (i) atleast one solid particulate component, in the form of tobacco particlesor other botanical particles (or both), the particulate componentpresent in an amount of at least about 5 dry weight percent (e.g., about5 to about 20 dry weight percent); (ii) a natural gum binder (e.g., gumarabic) present in an amount of at least about 25 dry weight percent(e.g., about 25 to about 35 dry weight percent); (iii) a plurality ofsugar alcohols present in an amount of at least about 40 dry weightpercent (e.g., about 40 to about 55 dry weight percent), the pluralityof sugar alcohols including isomalt or erythritol as the predominantcomponent (e.g., at least about 75% of total dry weight of sugaralcohols); (iv) salt present in an amount of at least about 4 dry weightpercent (e.g., about 4 to about 8 dry weight percent); (v) an optionalhumectant in an amount of at least about 1 dry weight percent (e.g.,about 1 to about 4 dry weight percent); (vi) an optional tobacco extract(including pharmaceutical grade nicotine) or other botanical extractpresent in an amount of at least about 0.1 dry weight percent (e.g.,about 0.1 to about 5 dry weight percent); and (vii) the balance beingone or more additional optional ingredients such as sweeteners (e.g.,sucralose), colorants, flavorants, and outer coating materials, each ofsuch additional optional ingredients present in an amount of less thanabout 3 dry weight percent (e.g., about 0.1 to about 3 dry weightpercent), all weight percentages based on the total dry weight of thepastille.

Still further, an exemplary pastille product useful for providing asensory experience similar to traditional snus tobacco comprises: (i) atleast one aqueous tobacco extract (including pharmaceutical gradenicotine) or other aqueous botanical extract (or both), the extractcomponent present in an amount of at least about 1 dry weight percent(e.g., about 1 to about 5 dry weight percent); (ii) a natural gum binder(e.g., gum arabic) present in an amount of at least about 30 dry weightpercent (e.g., about 30 to about 40 dry weight percent); (iii) aplurality of sugar alcohols present in an amount of at least about 45dry weight percent (e.g., about 45 to about 60 dry weight percent), theplurality of sugar alcohols including isomalt or erythritol as thepredominant component (e.g., at least about 75% of total dry weight ofsugar alcohols); (iv) salt present in an amount of less than about 4 dryweight percent (e.g., about 1 to about 3.5 dry weight percent); (v) anoptional humectant in an amount of at least about 1 dry weight percent(e.g., about 1 to about 4 dry weight percent); (vi) an optional solidparticulate tobacco or other botanical material present in an amount ofless than about 8 dry weight percent (e.g., about 1 to about 8 dryweight percent); and (vii) the balance being one or more additionaloptional ingredients such as sweeteners (e.g., sucralose), colorants,flavorants, and outer coating materials, each of such additionaloptional ingredients present in an amount of less than about 3 dryweight percent (e.g., about 0.001 to about 3 dry weight percent), allweight percentages based on the total dry weight of the pastille. Theparticular percentages and choice of ingredients will vary dependingupon the desired flavor, texture, and other characteristics.

All of the ingredients noted above for combination with a tobaccomaterial can be provided in a powder or granulated form for mixing withthe tobacco material formulation or provided in liquid form. Where theingredient is provided in a powder or granulated form, the averageparticle size is typically less than about 50 microns. According to someaspects, the average particle size of the ingredients may be about 25microns or less. The moisture content of the ingredients provided in apowder or granulated form may vary. Most preferably, the moisturecontent of the ingredient provided in a powder or granulated form isless than about 10 weight percent, and may be less than about 5 percent,and is often less than about 2.5 weight percent.

The manner by which the various components of the smokeless tobaccocomposition are combined may vary. The various components of thesmokeless tobacco composition may be contacted, combined, or mixedtogether in conical-type blenders, mixing drums, ribbon blenders, or thelike, such as a Hobart mixer. As such, the overall mixture of variousadditional ingredients with the tobacco materials may be relativelyuniform in nature. See also, for example, the types of methodologies setforth in U.S. Pat. No. 4,148,325 to Solomon et al.; U.S. Pat. No.6,510,855 to Korte et al.; and U.S. Pat. No. 6,834,654 to Williams, eachof which is incorporated herein by reference.

The ingredients forming the dissolvable smokeless tobacco compositionare prepared such that the mixture thereof may be used in a starchmoulding process for forming the smokeless tobacco product. Exemplarypastille production processes are set forth in U.S. Pat. No. 4,725,440to Ridgway et al and U.S. Pat. No. 6,077,524 to Bolder et al., which areincorporated by reference herein.

In one embodiment, the process comprises providing an aqueous mixturefor mixing with dry ingredients. In some instances, the aqueous mixturemay be formed by hydrating a binder material with water, and thenadmixing the hydrated binder with a sweetener and/or other liquid ordissolvable components, using a high shear mixer or a Hobart mixing bowlwith a whipping attachment. The liquid component mixed with the hydratedbinder, or even used to hydrate the binder, can include aqueouscomponents other than water, such as plant juices (which may befermented or non-fermented). Exemplary aqueous components include fruitjuice, vegetable juice, and wine. Such components can be useful forproviding hydration of the binder, and also useful for introducingfunctional properties associated with the botanical component from whichthe liquid is derived, such as certain sensory characteristics (e.g.,flavor, aroma, or color) or bioactivity or health benefits associatedwith the botanical. In particular, the addition of red wine can producefavorable changes in flavor and antioxidant properties of the smokelessproduct.

In a separate mixer, the plurality of sugar alcohols can be combined andheated to a high temperature, typically above the hard crack stage forthe predominant sugar alcohol. For instance, where isomalt is thepredominant ingredient, the sugar alcohol is melted and heated to above155° C. (e.g., about 160 to about 180° C.), optionally in the presenceof other less volatile ingredients such as salt, and then cooled andadded to the hydrated gum and mixed in thoroughly. This aqueous mixturetypically has a moisture content of at least about 30 percent by weightwater, based on the total weight of the mixture.

The aqueous mixture is mixed with a tobacco material or other botanicalmaterial (e.g., a particulate tobacco material and/or tobacco extract),and optionally other dry additives, in a Hobart mixing bowl to form asmokeless tobacco composition in slurry form. The smokeless tobaccocomposition may then be heated to an elevated temperature for a periodof time, for example, heated to between about 40° C. to about 80° C.,and typically heated to about 70° C., for a period of about 1 to about 3minutes. The resulting smokeless tobacco composition typically has amoisture content of at least about 25 percent by weight water, based onthe total weight of the mixture.

According to some aspects, the mixture may be put through a deaeratingstep or process prior to being received in a mould or being subjected toother processing steps, so as to reduce or eliminate air bubbles presentin the slurry mixture. Air bubbles entrapped within the mixture mayaffect the final weight of the smokeless tobacco product, which couldlead to a lack of weight uniformity between units of the final smokelesstobacco product. As such, any deaerating methods and systems may beemployed for removing such air bubbles from the mixture. For example,the mixture may be placed under reduced pressure (i.e., belowatmospheric pressure) to pull the air bubbles out of the slurry mixture.In some instances, a vacuum deaerating process may be employed in whichthe mixture is placed in a vacuum deaerator for deaerating the mixtureusing pressure reduction. In some instances, the mixture may be undervacuum for about 1 to about 10 minutes, and typically for about 3 toabout 5 minutes. The deaerating step may be observed and adjustedaccordingly in order to controllably remove the gaseous components fromthe mixture.

The viscosity of the heated and deaerated mixture may be measured using,for example, a Brookfield viscometer HA Series, SC4 water jacket, 27/13Rsample chamber and a No. 27 spindle. The mixture will typically have aviscosity of about 5.7 Pascal-seconds (Pa·s) to about 6.2 Pa·s whenheated to a temperature of about 38° C., about 4.9 Pa·s to about 5.4Pa·s when heated to a temperature of about 43° C., and about 4.2 Pa·s toabout 4.7 Pa·s when heated to a temperature of about 50° C. In someinstances, extra water may be added to the smokeless tobacco compositionso as to provide a desired viscosity thereof.

Once the desired viscosity is achieved, the heated smokeless tobaccocomposition may then be deposited into a mould, such as, for example, astarch mould. While the process as further described herein is directedto forming a smokeless tobacco product using a starch mould, it is notedthat other types of moulds may be used in the process, such as, forexample, starchless moulds, plastic tray moulds, metallic tray moulds,neoprene tray moulds, etc.

In instances involving the use of starch moulds, the starch moulds canbe pre-dried to remove moisture content from the starch mould itself.That is, prior to receiving the slurry or viscous smokeless tobaccocomposition, the starch mould may be subjected to an elevatedtemperature to drive out moisture in the starch mould. For example, insome instances, the starch mould may initially have a moisture contentof about 10-15 weight percent. Such levels of moisture could potentiallyhave an effect on the uniformity of the resultant product. In thisregard, certain moisture levels in the starch mould could potentiallyhave a wrinkling or pruning effect on the product such that the finalproduct has a shriveled or otherwise wrinkled appearance. As such, thestarch mould may be dried at an elevated temperature to reduce themoisture content of the starch mould to between about 4 and about 10weight percent, and preferably between about 6 and about 8 weightpercent, based on the total weight of the starch mould. By taking suchsteps, the product may, in some instances, be more uniformly consistentin appearance. Furthermore, the starch mould may be heated to anelevated temperature prior to receiving the smokeless tobaccocomposition such that the starch mould itself is at an elevatedtemperature when receiving the smokeless tobacco composition.

The smokeless tobacco composition remains in the starch mould at anelevated temperature such as, for example, between about 40° C. to about80° C. (e.g., at least about 40° C. or at least about 50° C.), andtypically about 60° C. The smokeless tobacco composition may be held atthe elevated temperature for a predetermined duration of time such as,for example, about 15-25 hours, so as to allow the smokeless tobaccocomposition to cure and solidify into pastille form, while driving themoisture content of the smokeless tobacco composition to a desired finalmoisture level. In this regard, curing generally refers to thesolidification process in which moisture loss occurs, the viscosity ofthe composition is raised, and chemical and physical changes begin tooccur (e.g., crystallization, cross-linking, gelling, film forming,etc.). The smokeless tobacco composition is allowed to cool andthereafter removed from the starch mould. In some instances, thesmokeless tobacco composition may be allowed to cool at refrigerated orbelow ambient temperatures. An air blower/shaker device can be used toremove starch remnants from the smokeless tobacco composition afterbeing removed from the starch mould.

The smokeless tobacco composition is then typically allowed to post-curefor a time and at a temperature suitable to allow the composition tobecome equilibrated to a desired moisture, shape and form. The time andtemperature can vary without departing from the invention and depend inpart on the desired final characteristics of the product. In oneembodiment, the post-cure is conducted at ambient temperature for atleast about 20 hours after being removed from the mould. The resultantpastille product may be provided in individual pieces weighing betweenabout 0.5 grams to about 5 grams, although aspects of the presentdisclosure are not limited to such weights.

The curing times and temperatures of the smokeless tobacco compositioncan be varied as desired. In this regard, such variables may affect thefinal visual appearance of the smokeless tobacco product. For example,extended curing times and/or low curing temperatures may affect thefinal outer configuration or contours of the smokeless tobacco product.That is, the rate of drying and/or curing of the product can affect thefinal properties of the product. In some instances, for example,lowering the curing temperature and extending the curing time may causethe smokeless tobacco product to have a relatively smooth outer surface.In contrast, curing at higher temperatures for shorter period of timescan lead to a roughened or wrinkled appearance in the product.

According to other aspects of the present disclosure, rather than usingmoulds to prepare the smokeless tobacco product, an extrusion processmay be employed in which the final smokeless tobacco product isextruded. In some instances, the smokeless tobacco composition in wetmixture form may be formed into a sheet and allowed to dry to a moisturecontent, for example, of about 15 percent to about 25 percent by weightwater to form a tacky or otherwise pasty material, which is in a formcapable of physical handling. The material may then be chopped orotherwise cut into smaller pieces using, for example, a mixer. Thechopped material may then be extruded through an extrusion device to anyshape/size desired, including shapes that may be difficult or impossibleto achieve with a mould. In some instances, the extruded product maythen be dried to achieve a desired moisture content. A similar typeprocess is described, for example, in U.S. Pat. No. 3,806,617 to Smylieet al., which is incorporated herein by reference in its entirety.Further, the smokeless tobacco composition may be subjected to aco-extrusion process with another composition.

Shapes such as, for example, rods and cubes can be formed by firstextruding the material through a die having the desired cross-section(e.g., round or square) and then optionally cutting the extrudedmaterial into desired lengths. Techniques and equipment for extrudingtobacco materials are set forth in U.S. Pat. No. 3,098,492 to Wursburg;U.S. Pat. No. 4,874,000 to Tamol et al.; U.S. Pat. No. 4,880,018 toGraves et al.; U.S. Pat. No. 4,989,620 to Keritsis et al.; U.S. Pat. No.5,072,744 to Luke et al.; U.S. Pat. No. 5,829,453 to White et al.; andU.S. Pat. No. 6,182,670 to White et al.; each of which is incorporatedherein by reference. Exemplary extrusion equipment suitable for useinclude food or gum extruders, or industrial pasta extruders such asModel TP 200/300 available from Emiliomiti, LLC of Italy. In someinstances, a single machine may be capable of achieving multiple stepsof the processes described herein, such as, for example, kneader systemsavailable from Buss AG.

According to some embodiments, the smokeless tobacco composition may becoated with a coating substance after being removed from the starchmould and prior to drying. For example, a glazing or anti-stickingcoating substance, such as, for example, CAPOL® 410 or 570C (availablefrom Centerchem, Inc.), may be applied to the smokeless tobaccocomposition to provide free-flowing properties. Outer coatings can alsohelp to improve storage stability of the smokeless tobacco products ofthe present disclosure as well as improve the packaging process byreducing friability and dusting. Devices for providing outer coatinglayers to the products of the present disclosure include pan coaters andspray coaters, and particularly include the coating devices available asCompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60 from ThomasEngineering. Additional coating compositions and methods of applicationare described in US Pat. Pub. No. 2012/0055494 to Hunt et al., which isincorporated by reference herein.

The smokeless tobacco pastille product can be dried or moistened toreach the final desired moisture level. The moisture content of thesmokeless tobacco product prior to use by a consumer can vary.Typically, the moisture content of the smokeless tobacco product, aspresent within a single unit of product prior to insertion into themouth of the user, is within the range of about 5 to about 20 weightpercent, often about 8 to about 15 weight percent, more often about 10to about 13 weight percent, based on the total weight of the productunit.

The acidity or alkalinity of the smokeless tobacco product, which isoften characterized in terms of pH, can vary and will depend, in part,on whether the product is formulated with a pH adjuster or bufferingagent. Typically, the pH of the formulation will fall within the rangeof about 4.5 to about 9. If a base or alkaline buffering agent ispresent, the pH is typically toward the upper end of the range, such asabout 6.5 to about 8. If the product is formulated without a pH adjusteror buffering agent, in certain embodiments, the pH will range from about4.5 to about 6.5. A representative technique for determining the pH of asmokeless tobacco formulation involves dispersing 5 g of thatformulation in 100 ml of high performance liquid chromatography water,and measuring the pH of the resulting suspension/solution (e.g., with apH meter).

The dissolvable smokeless tobacco pastille product can be provided inany suitable predetermined shape or form, and most preferably isprovided in the form having a general shape of a pill, pellet, tablet,coin, bead, ovoid, obloid, cube, or the like. The mouthfeel of thesmokeless tobacco product preferably has a slightly chewable anddissolvable quality with a mild resilience that allows malleabilityduring use. Preferably, the products do not, to any substantial degree,leave any residue in the mouth of the user thereof, and do not impart aslick, waxy, or slimy sensation to the mouth of the user. The pastilleis sized appropriately for insertion and manipulation in the oral cavityby the consumer, with typical outer dimensions including lengths andwidths of between about 10 mm and about 60 mm.

Although the foregoing description focuses on compositions that areuniform throughout each product unit, products can also be formed withmultiple different formulations having different properties in the sameproduct unit. For example, two different compositions can be depositedin a single mold to product a layered product. Still further, twodifferent compositions could be co-extruded to form a product withdifferent characteristics across its cross-section. Such a process couldbe used to provide a product with two different compositions featuringdifferent dissolution rates such that a first portion of the productdissolves at a first rate (e.g., a faster rate) and a second portiondissolves at a second, slower rate.

Products of the present disclosure may be packaged and stored in anysuitable packaging. See, for example, the various types of containersfor smokeless types of products that are set forth in U.S. Pat. No.7,014,039 to Henson et al.; U.S. Pat. No. 7,537,110 to Kutsch et al.;U.S. Pat. No. 7,584,843 to Kutsch et al.; D592,956 to Thiellier;D594,154 to Patel et al.; and D625,178 to Bailey et al.; US Pat. Pub.Nos. 2008/0173317 to Robinson et al.; 2009/0014343 to Clark et al.;2009/0014450 to Bjorkholm; 2009/0250360 to Bellamah et al.; 2009/0266837to Gelardi et al.; 2009/0223989 to Gelardi; 2009/0230003 to Thiellier;2010/0084424 to Gelardi; 2010/0133140 to Bailey et al.; 2010/0264157 toBailey et al.; 2011/0168712 to Bailey et al.; and 2011/0204074 toGelardi et al., which are incorporated herein by reference.

EXPERIMENTAL

The following examples are provided to illustrate further aspectsassociated with the present disclosure, but should not be construed aslimiting the scope thereof. Unless otherwise noted, all parts andpercentages are by dry weight.

Example 1

A pastille product adapted for use as a substitute for oral snuff isproduced using the following weight percentages of ingredients. Notethat the percentages listed in Table 1 include water.

TABLE 1 Wet weight percentages of ingredients Ingredient Wet Weight %Gum Arabic Powder 22.00 Cold Water (for hydration of gum) 22.00 IsomaltPowder 27.40 Erythritol 4.90 Maltitol Syrup 1.50 Glycerin 1.60 Sucralose0.04 Salt (sodium chloride) 4.50 Fire-cured Milled Tobacco 4.57Fire-cured tobacco spray-dried extract 3.00 Caramel Color 1.20 LicoriceFlavorant 0.370 Additional Flavorant 0.80 Water 6.00 Capol 570C(Centerchem, Inc.)* 0.070 *0.1% coating applied to finished product asanti-sticking agent

To prepare the product, two times the amount of gum arabic and water aremixed together in a high speed mixer for 30 minutes at a low speed. Thismixture is heated overnight at 60° C. and 25% relative humidity in acovered container. The mixture is removed from the heat source and foamyportion is discarded.

220 grams of hydrated gum arabic solution from above is weighed. Theactual grams of each ingredient listed here can vary depending on thebatch size, but the weight percentages will remain approximately thesame. The warm gum mixture is placed into a stirring cooker with paddleon slow and gently stirred while heating to about 155-160° F. (68 to 71°C.).

30 grams of water is weighed into a beaker. About 10.0 grams of salt isadded to the water and dissolved. The above indicated recipe levels ofsucralose (0.18 grams), Licorice flavor (1.85 grams), caramel color(6.00 grams) and glycerin (8.0 grams) are added to the water andstirred. This water mixture is then added to the stirring cooker.

In a separate heating pan, the isomalt powder (137.25 grams), erythritol(24.50 grams), and maltitol syrup (7.50 grams) are mixed together andheated to about 350° F. (177° C.). While this mixture is heating, about12.5 grams of salt is added to the stirring cooker. Following theaddition of the salt, the additional flavor (4.00 grams) is weighed andadded to the stirring cooker. After the isomalt, erythritol and maltitolmixture has been heated to desired temperature, this mixture is cooledto about 290° F. (143° C.) and then added slowly to the stirring cooker.The temperature in the stirring cooker increases, but cools quickly.Once the slurry in the stirring cooker is cooled to 160° F. (71° C.),the fire-cured milled tobacco (22.85 grams) and the fire-curedspray-dried Extract (15.00 grams) are added to the stirring cooker. Theslurry is stirred for one minute. The slurry is then poured into adepositor for depositing.

A starch bed is prepared by preheating a starch tray in 60° C., 25%relative humidity. An impression is made in the in the tray and filledwith the slurry using a depositor. After depositing the slurry into thetray, the deposited slurry pieces are covered with sifted corn starchsuch that there is about 1″ height of corn starch above the depositedpieces. The deposited trays are placed in an environmental cabinet for17 hours at 60° C., 25% relative humidity. The pieces are removed fromthe starch tray and the remaining starch is sprayed off 0.1% (0.35grams) level of anti-stick coating (Capol 570C) is applied by hand orusing a coating pan. The moisture level and pH is then measured. Priorto depositing, the starch moisture in the trays is approximately 6%moisture or less after pre-drying in the environmental cabinet. Thetargeted moisture content in each pastille is about 8% or less afterdrying. Table 2 below shows the dry weight percent of each ingredient ineach pastille made according to the procedure above, as well as theweight percent of each ingredient at a targeted 8% moisture contentlevel.

TABLE 2 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 8% Moisture Content Gum Arabic Powder 29.73 27.35Cold Water 0.00 8.00 Isomalt Powder 39.16 36.02 Erythritol 6.99 6.43Maltitol Syrup 1.69 1.55 Glycerin 2.38 2.19 Sucralose 0.06 0.05 Salt6.62 6.09 Fire-cured Milled Tobacco 6.11 5.62 Fire-cured Tobacco Spray-4.19 3.85 dried Extract Caramel Color 1.26 1.16 Licorice Flavorant 0.530.49 Additional Flavorant 1.19 1.09 Capol ® 570C 0.11 0.10

Example 2

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 1,except the milled tobacco is replaced with milled green tea, a differentcolorant is used, the licorice flavoring is removed, and less salt isused.

Table 3 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 12% moisture content level. The weightpercentages do not include a 0.2 weight percent Capol® 570C coatingapplied to the product.

TABLE 3 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 12% Moisture Content Gum Arabic Powder 33.29 29.29Cold Water 0.00 12.00 Isomalt Powder 42.46 37.36 Erythritol 7.32 6.44Maltitol Syrup 1.73 1.53 Glycerin 2.29 2.01 Sucralose 0.05 0.04 Salt2.27 1.99 Milled Green Tea 5.95 5.23 Spray-dried Tobacco 3.51 3.09Extract Blue Colorant 0.00 0.0000254 Flavorant 0.92 0.81

Example 3

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 2,except the milled green tea is removed.

Table 4 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 12% moisture content level. The weightpercentages do not include a 0.2 weight percent Capol® 570C coatingapplied to the product.

TABLE 4 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 12% Moisture Content Gum Arabic Powder 36.83 32.41Cold Water 0.00 12.00 Isomalt Powder 44.18 38.88 Erythritol 8.50 7.48Maltitol Syrup 1.86 1.64 Glycerin 2.76 2.43 Sucralose 0.05 0.05 Salt2.73 2.41 Spray-dried Tobacco 2.62 2.31 Extract Blue Colorant 0.000.0002558 Flavorant 0.46 0.41

Example 4

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 3,except microcrystalline cellulose (MCC) made from tobacco is added.

Table 5 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 12% moisture content level. The weightpercentages do not include a 0.2 weight percent Capol® 570C coatingapplied to the product.

TABLE 5 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 12% Moisture Content Gum Arabic Powder 31.83 28.01Cold Water 0.00 12.00 Isomalt Powder 43.82 38.56 Erythritol 8.22 7.24Maltitol Syrup 1.84 1.62 Glycerin 2.74 2.41 Sucralose 0.05 0.05 Salt2.71 2.39 Spray-dried Tobacco 2.66 2.34 Extract MCC Powder from 5.674.99 Tobacco Blue Colorant 0.00 0.0002537 Flavorant 0.46 0.40

Example 5

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 1,except a pharmaceutical grade nicotine composition is used as thetobacco extract component.

Table 6 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 12% moisture content level. The weightpercentages do not include a 0.2 weight percent Capol® 570C coatingapplied to the product.

TABLE 6 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 12% Moisture Content Gum Arabic Powder 37.05 32.61Cold Water 0.00 12.00 Isomalt Powder 44.45 39.11 Erythritol 8.55 7.52Maltitol Syrup 1.87 1.65 Glycerin 2.78 2.45 Sucralose 0.05 0.05 Salt2.75 2.42 Tobacco-derived Nicotine 2.26 1.99 Blue Colorant 0.000.0002573 Flavorant 0.23 0.20

Example 6

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 1, except for addition of lysine and sodium carbonate, which canbe added in the same step with the tobacco components.

Table 7 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 15% moisture content level.

TABLE 7 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 15% Moisture Content Gum Arabic Powder 31.60 26.86Cold Water 0.00 15.00 Isomalt Powder 35.28 29.99 Erythritol 6.35 5.40Maltitol Syrup 1.88 1.60 Lysine 0.33 0.28 Sodium carbonate 0.83 0.71Glycerin 2.65 2.25 Sucralose 0.06 0.05 Salt 7.37 6.27 Fire-cured MilledTobacco 5.89 5.00 Fire-cured Tobacco Spray- 3.08 2.62 dried ExtractCaramel Color 1.40 1.19 Licorice Flavorant 1.17 1.00 AdditionalFlavorant 1.83 1.56 Capol ® 570C 0.25 0.21

Example 7

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 1, except a pharmaceutical grade nicotine composition is used asthe tobacco extract component and the caramel color and licoriceflavorant are removed.

Table 8 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 8% moisture content level.

TABLE 8 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 8% Moisture Content Gum Arabic Powder 33.44 30.77Cold Water 0.00 8.00 Isomalt Powder 48.63 44.74 Erythritol 7.58 6.97Maltitol Syrup 1.63 1.50 Glycerin 2.30 2.11 Sucralose 0.01 0.01 Salt5.40 4.97 Tobacco-derived Nicotine 0.33 0.30 Flavorant 0.57 0.53 Capol ®570C 0.10 0.09

Example 8

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 1, except a pharmaceutical grade nicotine composition is used asthe tobacco extract component and Nutriose® soluble dietary fiber powder(available from Roquette of Lestrem, France) is added.

Table 9 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 10% moisture content level.

TABLE 9 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 10% Moisture Content Gum Arabic Powder 30.77 27.69Cold Water 0.00 10.00 Isomalt Powder 41.29 37.16 Erythritol 7.37 6.64Maltitol Syrup 1.78 1.60 Glycerin 2.04 1.84 Sucralose 0.02 0.02 Salt5.58 5.02 Tobacco-derived Nicotine 0.33 0.30 Nutriose ® Powder 8.40 7.56Caramel Color 1.12 1.01 Licorice Flavorant 0.50 0.45 AdditionalFlavorant 0.68 0.61 Capol ® 570C 0.11 0.10

Example 9

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 1, except the milled tobacco is replaced with milled green tea.

Table 10 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 8% moisture content level.

TABLE 10 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 8% Moisture Content Gum Arabic Powder 26.13 24.04Cold Water 0.00 8.00 Isomalt Powder 34.51 31.75 Erythritol 6.76 6.22Maltitol Syrup 1.63 1.50 Glycerin 2.30 2.12 Sucralose 0.05 0.05 Salt6.40 5.89 Milled Green Tea 15.17 13.96 Fire-cured Tobacco Spray- 4.053.73 dried Extract Caramel Color 1.22 1.12 Licorice Flavorant 0.51 0.47Additional Flavorant 1.15 1.06 Capol ® 570C 0.10 0.09

Example 10

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 9, except less milled green tea is used.

Table 11 below shows the dry weight percent of each ingredient in eachpastille made according to this procedure, as well as the weight percentof each ingredient at a targeted 12% moisture content level.

TABLE 11 Final product weight percentages Dry Weight Weight Percent atIngredient Percent 12% Moisture Content Gum Arabic Powder 29.58 26.03Cold Water 0.00 12.00 Isomalt Powder 39.07 34.38 Erythritol 6.95 6.12Maltitol Syrup 1.68 1.48 Glycerin 2.36 2.08 Sucralose 0.05 0.04 Salt6.58 5.79 Milled Green Tea 6.49 5.71 Fire-cured Tobacco Spray- 4.16 3.66dried Extract Caramel Color 1.26 1.11 Licorice Flavorant 0.53 0.46Additional Flavorant 1.18 1.04 Capol ® 570C 0.11 0.10

Example 11

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 5,except the erythritol was removed and replaced with additional isomalt.

Example 12

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 5,except from 1 to 5 dry weight percent of a honeybush extract is added.The isomalt and gum arabic components are reduced proportionately as aresult.

The honeybush extract is prepared by steeping honeybush powder in a 10part water to 1 part honeybush (by weight) slurry for about 10 minutesat a temperature of about 180° F. (about 82° C.). After steeping, theliquid extract is filtered through cheesecloth and the extractionprocess is repeated on the remaining pulp. The combined liquid extractis concentrated by evaporative drying and freeze-dried to form a powder.

Example 13

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 5,except from 1 to 5 dry weight percent of a green rooibos extract isadded. The isomalt and gum arabic components are reduced proportionatelyas a result.

The green rooibos extract is prepared by steeping green rooibos powderin a 10 part water to 1 part rooibos (by weight) slurry for about 10minutes at a temperature of about 180° F. (about 82° C.). Aftersteeping, the liquid extract is filtered through cheesecloth and theextraction process is repeated on the remaining pulp. The combinedliquid extract is concentrated by evaporative drying and freeze-dried toform a powder.

Example 14

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 13,except from 1 to 5 dry weight percent of a red (fermented) rooibosextract is added. The isomalt and gum arabic components are reducedproportionately as a result.

Example 15

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 5,except from 5 to 10 dry weight percent of a milled red (fermented)honeybush powder (less than about 50 micron average particle size) isadded. The milled honeybush powder is formed by grinding shreddedhoneybush leaves to the desired particle size. The isomalt and gumarabic components are reduced proportionately as a result.

Example 16

A pastille product adapted for use as a substitute for snus is producedusing the same general process and formulation set forth in Example 5,except from 5 to 10 dry weight percent of a milled green rooibos powder(less than about 50 micron average particle size) is added. The milledrooibos powder is formed by grinding shredded rooibos leaves to thedesired particle size. The isomalt and gum arabic components are reducedproportionately as a result.

Example 17

A pastille product adapted for use as a substitute for oral snuff isproduced using the same general process and formulation set forth inExample 1, except about 4 dry weight percent of milled rosemary powder(less than about 50 micron average particle size) is added to theproduct. The milled rosemary powder is formed by grinding shreddedrosemary leaves to the desired particle size. The isomalt and gum arabiccomponents are reduced proportionately as a result.

Many modifications and other embodiments of the invention will come tomind to one skilled in the art to which this invention pertains havingthe benefit of the teachings presented in the foregoing description.Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

That which is claimed:
 1. A smokeless tobacco pastille configured forinsertion into the mouth of a user, the smokeless tobacco pastillecomprising: (i) a tobacco material present in an amount of less thanabout 40 dry weight percent, based on the total dry weight of thepastille; (ii) at least one natural gum binder present in an amount ofat least about 25 dry weight percent; and (iii) a plurality of sugaralcohols present in a total amount of at least about 40 dry weightpercent, the predominant component of the plurality of sugar alcoholsbeing isomalt or erythritol, wherein the shape of the smokeless tobaccopastille is moldable in the oral cavity.
 2. The smokeless tobaccopastille of claim 1, wherein the only tobacco material present in thepastille is in the form of one or more tobacco extracts present inamount of less than about 10 dry weight percent.
 3. The smokelesstobacco pastille of claim 2, wherein the one or more tobacco extractscomprise an aqueous extract.
 4. The smokeless tobacco pastille of claim2, wherein the one or more tobacco extracts comprises a pharmaceuticalgrade nicotine.
 5. The smokeless tobacco pastille of claim 1, whereinthe tobacco material comprises a particulate tobacco material present inan amount of less than about 12 dry weight percent.
 6. The smokelesstobacco pastille of claim 5, wherein the particulate tobacco materialhas an average particle size of less than about 50 microns.
 7. Thesmokeless tobacco pastille of claim 1, wherein the pastille furthercomprises an additional non-tobacco botanical component, and wherein thetotal amount of tobacco material and non-tobacco botanical component isless than about 40 dry weight percent.
 8. The smokeless tobacco pastilleof claim 7, wherein the non-tobacco botanical component is selected fromthe group consisting of rosemary, oregano, sage, hibiscus, clove, rosehip, yerba mate, cocoa, turmeric, guayusa, honeybush, green tea, blacktea, rooibos, and combinations thereof.
 9. The smokeless tobaccopastille of claim 1, wherein the natural gum binder comprises gumarabic.
 10. The smokeless tobacco pastille of claim 1, wherein thenatural gum binder is selected from the group consisting of gum arabic,xanthan gum, guar gum, ghatti gum, gum tragacanth, karaya gum, locustbean gum, gellan gum, and combinations thereof.
 11. The smokelesstobacco pastille of claim 1, wherein the natural gum binder is presentin an amount of about 25 to about 40 dry weight percent.
 12. Thesmokeless tobacco pastille of claim 1, wherein, in addition to isomalt,the plurality of sugar alcohols comprise one or more sugar alcoholsselected from the group consisting of erythritol, arabitol, ribitol,isomalt, polyglycitol, maltitol, dulcitol, iditol, mannitol, xylitol,lactitol, sorbitol, and combinations thereof.
 13. The smokeless tobaccopastille of claim 1, wherein the isomalt comprises at least about 75% ofthe total dry weight of the plurality of sugar alcohols.
 14. Thesmokeless tobacco pastille of claim 1, wherein the plurality of sugaralcohols comprises at least two additional sugar alcohols.
 15. Thesmokeless tobacco pastille of claim 14, wherein the at least twoadditional sugar alcohols are present in a dry weight ratio of at leastabout 3:1.
 16. The smokeless tobacco pastille of claim 15, wherein thepastille comprises erythritol or sorbitol and either maltitol orxylitol, present in a dry weight ratio of at least about 3:1, witherythritol or sorbitol being the larger component.
 17. The smokelesstobacco pastille of claim 1, further comprising one or more additionalcomponents selected from the group consisting of flavorants, sweeteners,additional binders, emulsifiers, disintegration aids, humectants,colorants, buffering agents, and mixtures thereof.
 18. The smokelesstobacco pastille of claim 1, further comprising a humectant.
 19. Thesmokeless tobacco pastille of claim 18, wherein the humectant isglycerin.
 20. The smokeless tobacco pastille of claim 1, furthercomprising sucralose.
 21. The smokeless tobacco pastille of claim 1,wherein the pastille has an outer coating coated thereon.
 22. Thesmokeless tobacco pastille of claim 1, wherein the pastille isstarch-moulded.
 23. The smokeless tobacco pastille of claim 1, furthercomprising one or more of green tea, guayusa, rooibos, or honeybush. 24.The smokeless tobacco pastille of claim 23, wherein the one or more ofgreen tea, guayusa, rooibos, or honeybush is present as an aqueousextract in an amount of about 1 to about 5 dry weight percent, or in theform of a powder in an amount of about 5 to about 10 dry weight percent.25. The smokeless tobacco pastille of claim 1, comprising: (i) at leastone solid particulate component, in the form of tobacco particles ornon-tobacco botanical particles or both, the particulate componentpresent in an amount of at least about 5 dry weight percent; (ii) anatural gum binder present in an amount of at least about 25 dry weightpercent; (iii) a plurality of sugar alcohols present in an amount of atleast about 40 dry weight percent, the plurality of sugar alcoholsincluding isomalt or erythritol in an amount of at least about 75% ofthe total dry weight of sugar alcohols; (iv) salt present in an amountof at least about 4 dry weight percent; and (v) a humectant in an amountof at least about 1 dry weight percent.
 26. The smokeless tobaccopastille of claim 25, further comprising a tobacco extract ornon-tobacco botanical extract present in an amount of at least about 0.1dry weight percent.
 27. The smokeless tobacco pastille of claim 1,comprising: (i) at least one aqueous tobacco extract or other aqueousnon-tobacco botanical extract or both, the extract component present inan amount of at least about 1 dry weight percent; (ii) a natural gumbinder present in an amount of at least about 30 dry weight percent;(iii) a plurality of sugar alcohols present in an amount of at leastabout 45 dry weight percent, the plurality of sugar alcohols includingisomalt or erythritol in an amount of at least about 75% of the totaldry weight of sugar alcohols; (iv) salt present in an amount of lessthan about 4 dry weight percent; and (v) a humectant in an amount of atleast about 1 dry weight percent.